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    MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA

    The US Food and Drug Administration (FDA) on Tuesday proposed increasing user fees for medical device manufacturers by more than $320 million over the next five years, according to a draft proposal for MDUFA IV. The new funding will enable FDA to implement a number of proposed enhancements, with additional funding (amounts will also be adjusted for inflation each year) to be phased in over each fiscal year (FY) as follows: $47,419,400 for FY 2018 $54,849,400 for FY...
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    BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

    A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...
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    NICE to Charge up to £282,000 for Each New Drug Assessment

    The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year. News of the new fees stirred controversy in London’s Sunday Times , and a NICE spokesman emailed Focus on Monday with NICE Chief Executive Sir Andrew Dillon’s response to that story on the fees for technology appraisal and guidance: “Charging pharmaceutica...
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    CDSCO Advances Draft Medical Device Rules, Outlines Fees

    India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders. In June, India announced it was abandoning its plan to amend the Drugs and Cosmetics Act of 1940 in favor of developing new, separate legislation for the regulation of drugs and medical devices. Shortly afterwards, CDSCO released preliminary draft rules est...
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    PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals

    More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a  46-page document  outlining how the agency ...
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    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
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    PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

    Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA ) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a 46-page document outlining how the agency will use t...
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    FDA Unveils User Fee Rates for FY 2017

    In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees fr...
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    Medical Device Companies to See Slight Discount in FDA User Fees in 2017

    Medical device companies will see a modest decrease in application fees for FY 2017 when compared to 2016, according to new fee rates released Thursday by the US Food and Drug Administration (FDA). The 2017 standard fee for a premarket application, premarket report and efficacy supplement (in effect from 1 October 2016 to 30 September 2017) will be $234,495, which is $26,893 less than FY 2016’s fees . Panel-track supplement fees, however, will reach their lowe...
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    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
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    FDA Lowers ANDA Fee Rates for 2017

    Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016. For FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016 ), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in ...
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    The Next PDUFA: New Performance and Procedural Goals

    Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022. The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projec...